#Glenmark opens new manufacturing facility in #Switzerland

Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited, India (GPL), announced the opening of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland. This manufacturing facility supplements Glenmark’s existing in-house discovery and development capabilities and will supply material for clinical development.
Glenmark Pharmaceuticals’ Swiss research center is an integrated antibody discovery and development unit. The research center has fully developed in-house capabilities and infrastructure for conducting antibody discovery, cell line development, in vitro testing and characterization of antibodies, process development and analytical research. The new manufacturing facility supplements the research and development capabilities and will facilitate production of clinical grade material.
The manufacturing facility has been designed for use of single use bioreactor systems and also houses a suite for manufacturing cell banks. The facility is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material.
 Dr. Michael Buschle, President – Biologics, Glenmark Pharmaceuticals Ltd. commented, “This state of the art manufacturing facility is a testimony for Glenmark’s commitment to growing its R&D and manufacturing facility in the canton of Neuchâtel. We have been doing cutting edge work in the area of novel monoclonal antibodies and have several monoclonal antibody candidates & bispecific antibodies in the pipeline. The manufacturing facility would help us bring these antibodies to the clinic faster and position Glenmark as a leading innovative pharmaceutical company.”  Glenmark’s biologics research center in Switzerland has a robust pipeline of monoclonal antibodies in various stages of development including bispecific antibodies. The focus for the biologics R&D center is to develop novel biologic entities for the treatment of pain, inflammatory, oncologic and respiratory conditions. Glenmark currently has 69 employees at its biologic research center.
 In its short existence of just about 10 years, Glenmark’s biologics research center has filed several patents on novel biologic entities. GBR 500 its most advanced candidate has been licensed to Sanofi and is currently in Phase 2 development. GBR 900, a first-in-class molecule for treatment of chronic pain is currently in Phase 1 and GBR 830, an anti OX-40 antagonist, is scheduled to enter the clinic later this year. The scientists at Glenmark have also invented a best-in-class technology platform to manufacture bispecific antibodies, BEAT™.

Glenmark announces landmark deal worth USD 613 million - Outlicenses its novel monoclonal antibody to Sanofi

Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announced today that it has entered into an agreement with Sanofi to grant Sanofi a license for the development and commercialization of GBR 500, a novel monoclonal antibody for the treatment of Crohn’s Disease and other inflammatory conditions. The transaction is expected to close in the coming month subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart‐Scott‐Rodino Antitrust Improvements Act. Under the terms of the agreement, Glenmark will receive an upfront payment of US$ 50 million, of which US$ 25 million will be paid upon closing of the transaction and US$ 25 million, which is contingent upon Sanofi’s positive assessment of certain data to be provided by Glenmark. In addition, Glenmark could receive potential success‐based development,regulatory and commercial milestone payments. The total of these payments could reach US$613 Mn. In addition, Glenmark is eligible to receive tiered double‐digit royalties on sales of products commercialized under the license. Sanofi will have exclusive marketing rights for North America, Europe, Japan, Argentina, Chile and Uruguay. Sanofi and Glenmark will comarket in Russia, Brazil, Australia and New Zealand, and Glenmark will retain exclusive marketing rights in India and other countries in the rest of the world.

GBR 500 is an antagonist of the VLA‐2 (alpha2‐beta1) integrin. It is a first‐in‐class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti‐inflammatory conditions. Glenmark has completed Phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn’s Disease. Sanofi has licensed the rights to all therapeutic indications.

“There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases,” said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. “GBR500 brings an innovative approach to Sanofi’s Immuno‐Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients”.


According to Glenn Saldanha MD and CEO of GPL, “This collaboration on a novel first‐inclass monoclonal antibody validates Glenmark’s world‐class innovative R&D capabilities in the drug discovery arena. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics”.

Dr. Michael Buschle, President Biologics for Glenmark commented, “The focus for the Switzerland biologics R&D centre has been to discover and develop exciting novel monoclonal antibodies for the potential treatment of inflammatory and oncology conditions.This deal is a testimony to the strong biologics platform that Glenmark has established in a relatively short frame of time.”

About Glenmark

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceuticalcompany headquartered at Mumbai, India. It is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis, IBD, etc.] and Pain [neuropathic pain and inflammatory pain].
The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.

About Sanofi

Sanofi, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi is listed in Paris and in New York.